Trestle Luxe 71002-032Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844856067004), received between Apr 20, 2018 and Sep 11, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K102820); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2019Break; Detachment of Device or Device Component

  WHILE INSERTING THE SCREWS, THE GOLD TAB BROKE OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8992776 ↗
• MalfunctionApr 20, 2018Break; Detachment Of Device Component; Device Operates Differently Than Expected

  WHILE ATTEMPTING TO BEND THE PLATE, THE MIDDLE BLOCKING SLIDE BROKE/DETACHED FROM THE IMPLANT. THERE WERE NO PATIENT COMPLICATIONS. ANOTHER PLATE WAS SELECTED, BENT AND IMPLANTED WITHOUT ISSUE.

  Patient problems: No Information

  MAUDE report 7446576 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102820. One submission often covers many models, so check the product and lot details in each record.

• Z-1547-2015 · Apr 10, 2015 · Terminated
  4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphat
• Z-2273-2012 · May 29, 2012 · Terminated
  TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cerv